Medical Device Manufacturer · US , Bridgewater , NJ

Direct Access Diagnostics - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1996

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Direct Access Diagnostics Chemistry ✕

2 devices

1-2 of 2

Cleared Nov 18, 1996

FACT PLUS PREGNANCY TEST

Chemistry · 34d

Cleared Jul 29, 1996

FACTPLUS ONE STEP PREGNANCY TEST

Chemistry · 40d